Importer of Controlled Substances; Notice of Application, 75495 [2010-30348]
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Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices
a registration under this Section to a
bulk manufacturer of a controlled
substance in schedule I or II, and prior
to issuing a regulation under 21 U.S.C.
952(a)(2) authorizing the importation of
such a substance, provide
manufacturers holding registrations for
the bulk manufacture of the substance
an opportunity for a hearing.
Therefore, in accordance with 21 CFR
1301.34(a), this is notice that on June 4,
2010, Clinical Supplies Management,
Inc., 342 42nd Street South, Fargo,
North Dakota 58103, made application
by renewal to the Drug Enforcement
Administration (DEA) to be registered as
an importer of Sufentanil (9740), a basic
class of controlled substance listed in
schedule II.
The company plans to import the
listed controlled substance with the sole
purpose of packaging, labeling, and
distributing to customers which are
qualified clinical sites conducting
clinical trials under the auspices of an
FDA-approved clinical study.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic class of controlled substance
may file comments or objections to the
issuance of the proposed registration,
and may, at the same time, file a written
request for a hearing on such
application pursuant to 21 CFR 1301.43,
and in such form as prescribed by 21
CFR 1316.47.
Any such comments or objections
should be addressed, in quintuplicate,
to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than January 3, 2011. This
procedure is to be conducted
simultaneously with, and independent
of, the procedures described in 21 CFR
1301.34(b), (c), (d), (e), and (f). As noted
in a previous notice published in the
Federal Register on September 23, 1975,
(40 FR 43745–46), all applicants for
registration to import a basic class of
any controlled substance in schedule I
or II are, and will continue to be,
required to demonstrate to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
VerDate Mar<15>2010
16:09 Dec 02, 2010
Jkt 223001
Dated: November 18, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2010–30344 Filed 12–2–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
Pursuant to 21 U.S.C. 958(i), the
Attorney General shall, prior to issuing
a registration under this Section to a
bulk manufacturer of a controlled
substance in schedule I or II, and prior
to issuing a regulation under 21 U.S.C.
952(a)(2) authorizing the importation of
such a substance, provide
manufacturers holding registrations for
the bulk manufacture of the substance
an opportunity for a hearing.
Therefore, in accordance with 21 CFR
1301.34(a), this is notice that on July 28,
2010, Fisher Clinical Services, Inc.,
7554 Schantz Road, Allentown,
Pennsylvania 18106, made application
by renewal to the Drug Enforcement
Administration (DEA) to be registered as
an importer of the basic classes of
controlled substances listed in schedule
II:
Drug
Schedule
Noroxymorphone (9668) ..............
Tapentadol (9780) ........................
II
II
The company plans to import the
listed substances for analytical research
and clinical trials.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances may file comments or
objections to the issuance of the
proposed registration, and may, at the
same time, file a written request for a
hearing on such application pursuant to
21 CFR 1301.43, and in such form as
prescribed by 21 CFR 1316.47.
Any such comments or objections
should be addressed, in quintuplicate,
to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than January 3, 2011.
This procedure is to be conducted
simultaneously with, and independent
of, the procedures described in 21 CFR
1301.34(b), (c), (d), (e), and (f). As noted
in a previous notice published in the
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75495
Federal Register on September 23, 1975,
(40 FR 43745–46), all applicants for
registration to import a basic class of
any controlled substance in schedule I
or II are, and will continue to be,
required to demonstrate to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
Dated: November 18, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2010–30348 Filed 12–2–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
Pursuant to 21 U.S.C. 958(i), the
Attorney General shall, prior to issuing
a registration under this Section to a
bulk manufacturer of a controlled
substance in schedule I or II, and prior
to issuing a regulation under 21 U.S.C.
952(a)(2) authorizing the importation of
such a substance, provide
manufacturers holding registrations for
the bulk manufacture of the substance
an opportunity for a hearing.
Therefore, in accordance with 21 CFR
1301.34(a), this is notice that on
September 13, 2010, Chattem
Chemicals, Inc., 3801 St. Elmo Avenue,
Building 18, Chattanooga, Tennessee
37409, made application by letter to the
Drug Enforcement Administration
(DEA) to be registered as an importer of
4-Anilino-N-Phenethyl-4-Piperidine
(ANPP) (8333), a basic class of
controlled substance listed in schedule
II.
The company plans to import this
controlled substance in bulk for use in
the manufacture of another controlled
substance.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic class of controlled substance
may file comments or objections to the
issuance of the proposed registration,
and may, at the same time, file a written
request for a hearing on such
application pursuant to 21 CFR 1301.43,
and in such form as prescribed by 21
CFR 1316.47.
Any such comments or objections
should be addressed, in quintuplicate,
E:\FR\FM\03DEN1.SGM
03DEN1
Agencies
[Federal Register Volume 75, Number 232 (Friday, December 3, 2010)]
[Notices]
[Page 75495]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30348]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application
Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to
issuing a registration under this Section to a bulk manufacturer of a
controlled substance in schedule I or II, and prior to issuing a
regulation under 21 U.S.C. 952(a)(2) authorizing the importation of
such a substance, provide manufacturers holding registrations for the
bulk manufacture of the substance an opportunity for a hearing.
Therefore, in accordance with 21 CFR 1301.34(a), this is notice
that on July 28, 2010, Fisher Clinical Services, Inc., 7554 Schantz
Road, Allentown, Pennsylvania 18106, made application by renewal to the
Drug Enforcement Administration (DEA) to be registered as an importer
of the basic classes of controlled substances listed in schedule II:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Noroxymorphone (9668)...................... II
Tapentadol (9780).......................... II
------------------------------------------------------------------------
The company plans to import the listed substances for analytical
research and clinical trials.
Any bulk manufacturer who is presently, or is applying to be,
registered with DEA to manufacture such basic classes of controlled
substances may file comments or objections to the issuance of the
proposed registration, and may, at the same time, file a written
request for a hearing on such application pursuant to 21 CFR 1301.43,
and in such form as prescribed by 21 CFR 1316.47.
Any such comments or objections should be addressed, in
quintuplicate, to the Drug Enforcement Administration, Office of
Diversion Control, Federal Register Representative (ODL), 8701
Morrissette Drive, Springfield, Virginia 22152; and must be filed no
later than January 3, 2011.
This procedure is to be conducted simultaneously with, and
independent of, the procedures described in 21 CFR 1301.34(b), (c),
(d), (e), and (f). As noted in a previous notice published in the
Federal Register on September 23, 1975, (40 FR 43745-46), all
applicants for registration to import a basic class of any controlled
substance in schedule I or II are, and will continue to be, required to
demonstrate to the Deputy Assistant Administrator, Office of Diversion
Control, Drug Enforcement Administration, that the requirements for
such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and
21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied.
Dated: November 18, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2010-30348 Filed 12-2-10; 8:45 am]
BILLING CODE 4410-09-P